About Us

OUR COMPANY AT A GLANCE

Biotech Solns Int’l is a firm assisting companies to achieve and maintain compliance with all FDA requirements.
We provide Workforce Solutions, Engineering Consulting, and Project Services for the Medical Device, Biologics, and Pharmaceutical Industries.

OUR MISSION

Prevent and resolve compliance issues are the heart of our firm's experience and expertise

Help ensure your organization's success through careful analysis and high-quality work products.

Our team is a powerful blend of consultants with FDA and industry experience — including leading scientific and technical experts who help ensure that recommendations are not only scientifically and technically accurate, but also actionable.

OUR FIRM'S STRENGTHS

We have successfully resolved many compliance challenges for our clients both with the FDA and the EU.

OUR SERVICE BENEFIT:

Dealing with the Food and Drug Administration is no easy task. Our firm can assist your organization in writing and implementing its Quality System or enhancing its ISO Quality System to conformance to Part 820.

The Food and Drug Administration 483 Observations have increased due to the fact that the FDA has more Inspectors who have the time to perform in-depth inspections. Our firm has the knowledge and experience to help clients remediate compliance issues and prevent recurrence.